Remote Ischaemic Postconditioning in the Clinical Setting of NSTEACS and Urgent PCI

Not Applicable

Completed

• Conditions: Post Procedural Myocardial Infarction
• Interventions: Device: Sham protocol; Device: Remote Conditioning

• Registration Number: NCT03726164
• Lead Sponsor: University College, London

Brief Summary

This study investigates the cardioprotective effect of remote ischaemic pre-/postconditioning in patients presenting with a NSTEMI/Unstable angina undergoing PCI.

Detailed Description

Patients presenting with Non ST elevation acute coronary syndromes (NSTEACS) - NSTEMI and Unstable angina patients are enrolled in this study.

Eligible patients are approached, with patient information sheets and are consented for involvement into the study. Patients are randomised to intervention or control. Patients randomised to intervention will receive 3 x 5 minutes of forearm ischaemia (with the cuff inflated to 200 mmHg) separated by 5 minutes of reperfusion between each cuff inflation, prior coronary angiography.

This protocol of episodic forearm ischaemia/reperfusion has been demonstrated to confer remote ischaemic preconditioning-induced protection.

Prior to the intervention, a blood sample will be taken to measure serum troponin T and CK-MB (baseline level). Following PCI patients will be reviewed on the wards and their ongoing recovery will be assessed and reviewed prior to discharge from the study. Troponin T and CK-MB levels will be measured for the 24 hours after PCI, at various time points (6 hour, 12 hour, 24 hour) as a measure of the degree of myocardial damage, and levels compared between the different treatment groups.

Primary end point

Myocardial injury (Peri-procedural Myocardial Infarction and Injury) measured by cTnT and CK-MB release over 24 hours after primary PCI.

Study Timeline

• Study Start: 2008-06
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2017-05
• Study First Submitted: 2017-05-08
• Study First Submitted QC: 2018-10-29
• Study First Posted: 2018-10-31
• Results First Submitted: 2020-11-04
• Results First Submitted QC: 2020-11-04
• Last Update Submitted: 2020-11-04
• Results First Posted: 2020-12-01
• Last Update Posted: 2020-12-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 626

Inclusion Criteria

• Patients admitted with NSTEMI/ Unstable angina undergoing percutaneous intervention

Exclusion Criteria

• Known renal failure
• Known liver disease
• Peripheral vascular disease involving upper limbs
• Inability to consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Sham protocol	Patients will receive a standard sham remote ischaemia preconditioning protocol with an un-inflated cuff be placed on the arm in this group of patients for 30 minutes. This is the sham intervention for this group.
Remote Conditioning group	Remote Conditioning	Patients will receive a standard remote ischaemia preconditioning protocol comprising a blood pressure cuff placed on arm and inflated to 200mmHg for 5 minutes and then deflated for 5 minutes, a cycle repeated three times, prior to the PCI procedure.

Primary Outcome Measures

Name	Time	Method
Peri-Procedural Myocardial Injury	24 hours post PCI	Peri-Procedural Myocardial Injury will be assessed by the number of patients with peak troponin-T\>3x 99th percentile upper reference limit